Early Rehabilitation of COPD Patients in ICU

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00628992
First received: February 4, 2008
Last updated: September 15, 2011
Last verified: September 2011

February 4, 2008
September 15, 2011
February 2008
March 2013   (final data collection date for primary outcome measure)
Number day breathing without assistance during the 28-day study period [ Time Frame: during the 28-day study period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00628992 on ClinicalTrials.gov Archive Site
  • Mortality at day 28 and day 90 [ Time Frame: Measured within the ICU stay of the patient ] [ Designated as safety issue: No ]
  • Length of stay in intensive care unit and hospital [ Time Frame: Measured within the ICU stay of the patient ] [ Designated as safety issue: No ]
  • Clinical measurement of muscular strength in lower limbs(day 0-2 and day 28-30) [ Time Frame: Measured within the ICU stay of the patient ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Early Rehabilitation of COPD Patients in ICU
Effects of Early Rehabilitation in Chronic Obstructive Pulmonary Disease Patients Under Mechanical Ventilation for Acute Respiratory Failure in Intensive Care Unit.

Twenty per cent of the intensive care patients mechanically ventilated suffer from chronic obstructive pulmonary disease (COPD). These patients stay longer in Intensive Care which is more costly and they are more prone to nosocomial infection.In addition, they are longer bedridden and they develop muscular weakness.Prolonged inactivity results in respiratory and skeletal muscle weakness which curtails simple daily activity.The principal purpose of this study is to compare two types of muscular rehabilitation (electrical stimulation of the thigh and/or cycloergometer training) to classic passive mobilization of the leg.The second purpose is to analyse the effects of each type of rehabilitation on muscular fiber (structural and functional analysis) by muscular biopsies.Two hundred forty COPD patients admitted in the intensive care unit for acute respiratory failure will be randomized in 4: 1 fashion to receive passive mobilization of the legs(group 1, n=60), electrical stimulation of the thigh (group 2, n=60), cycloergometer training (group 3, n=60) or electrical stimulation of the thigh and cycloergometer training(group 4, n=60).The rehabilitation program will last 4 weeks with 5 sessions per week.In each group of patients, muscular biopsies will be done under local anaesthesia at the beginning and end of the rehabilitation programme and when they are discharged from the service.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Obstructive Pulmonary Disease
  • Acute Respiratory Failure
  • Other: No specific intervention, standard therapy serving as a control group, passive mobilization of the legs
    Muscular rehabilitation of the leg
  • Other: Electrical stimulation of the thigh
    Muscular rehabilitation of the leg
  • Other: Cycloergometer training
    Muscular rehabilitation of the leg
  • Other: Electrical stimulation of the thigh and cycloergometer training
    Muscular rehabilitation of the leg
  • 1
    Intervention: Other: No specific intervention, standard therapy serving as a control group, passive mobilization of the legs
  • Active Comparator: 2
    Intervention: Other: Electrical stimulation of the thigh
  • Active Comparator: 3
    Intervention: Other: Cycloergometer training
  • Active Comparator: 4
    Intervention: Other: Electrical stimulation of the thigh and cycloergometer training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
240
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient older than 18 years of age
  • Chronic obstructive pulmonary disease
  • Intubated with mechanical ventilation
  • Patients without sedation or catecholamine
  • 2 previous spontaneous breathing trial at 24 hour intervals with T-piece having been unsuccessful
  • Conscious and cooperative state
  • Ability for the patient to sit in a armchair

Exclusion Criteria:

  • Non chronic obstructive pulmonary disease
  • Lack of patient involvement
  • Minor Patients
  • Patients under guardianship
  • Unconscious and non cooperative state
  • Patients unable to ride in a wheelchair
  • Patients not affiliated with a Social Security System
  • Patients under justice safeguard
  • Patients under curator ship
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00628992
3912
Not Provided
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Not Provided
Principal Investigator: Vincent CASTELAIN, MD Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP